From Regulatory Approval to Clinical Efficacy: The Road Less Traveled by
نویسنده
چکیده
Innovative advancements in bedside applications can save, extend, and improve the quality of life for patients worldwide. Innovation addresses specific unmet needs when evaluated clinically for safety and efficacy. However, the process does not stop there. A post-market surveillance program is usually in place to address design and performance issues surfacing post product release, which is further enhanced by case reported outcomes from users [the clinical/surgical community] and their patients. This dynamic is captured in the Case Report featured by the Journal of Materials Science: Materials in Medicine March edition, entitled: “Debris of carbon-fibers originated from a CFRP (pEEK) wrist-plate triggered a destruent synovitis in human” [free article download].
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تاریخ انتشار 2016